Kornimate/medical-research-clean huggingface dataset:
neuroscience of marijuana impaired driving

Conditions: Marijuana Impairment

Summary: marijuana is one of the most widely used substances. however, marijuana intoxication is not fully understood in relation to driving. this study will help the investigators learn more about the potential impairments related to marijuana intoxicated driving. a combination of mri and neuropsychological tests (which are computer and paper/pencil tasks) will be used to measure intoxication and impairment. this study will also assess levels of marijuana in blood and saliva samples. this study takes place in hartford, connecticut.

cannabis is a commonly abused drug whose use cuts across social class, is linked to cognitive impairment, and may be a major contributor to intoxication-related accidents - either alone or with alcohol. however, cannabis intoxication is little studied in relation to driving compared to alcohol. not only does the current nhtsa strategic plan for behavioral research prioritize understanding how drugs other than alcohol contribute to traffic crashes, it has recently become more pressing to understand the effects of cannabis because of increasing rates of legalized medical and/or recreational use, that will likely result in more cannabis intoxicated drivers. social and legal policy will be unable to effectively address the many concerns about driving safety raised by more frequent and widespread use of cannabis without new research to better determine the parameters within which cannabis use does, or does not, increase automobile accident risk. the purpose of this study is to better describe specific, driving-related cognitive impairments caused by acute cannabis intoxication, their persistence over time, underlying functional brain anatomy, and relationship to performance on a state-of the art validated simulated driving task in which the investigators have prior experience. in a randomized, counterbalanced, double-blinded fashion, the investigators will administer two cannabis doses and placebo of smoked cannabis (paced inhalation using a vaporizer) to 48 regular cannabis users and 48 occasional cannabis users on 3 separate occasions. following cannabis dosing cognitive and driving impairment will be assessed longitudinally for several hours using a combination of fmri and neuropsychological tests, to clarify relationships between subjective and objective measures of intoxication and of impairment, that include expert assessment of thc and its metabolite levels in blood and saliva. this study takes place in hartford, connecticut.

Eligibility criteria:
inclusion criteria: * must have a current driver's license * have used marijuana before * right handed exclusion criteria: * females who are pregnant or breast feeding * unable or unsafe to have an mri * any serious medical, or neurological disorder * any psychiatric disorder * no major head traumas

Keywords: marijuana driving thc cannabis intoxication mri
behavioural activation for bipolar depression

Conditions: Bipolar Depression

Summary: bipolar disorder (bd) affects between 1-3% of the world's population. people with bd experience episodes of mania or hypomania and in most cases, they experience periods of depression which can cause difficulties in daily life. psychological therapies for people experiencing depression without mania or hypomania are widely available, but there is little research into how effective these therapies are for people with bd. behavioral activation therapy (ba) is based on behavioral theory and has been proven to be an effective treatment for unipolar depression. it helps people re-establish healthier activity patterns and sleep regulation, especially in bd for mood stabilization. ba is theoretically and clinically well matched to the treatment of bipolar depression, but there is still very little research into offering ba to people with bd. the first aim of the current research is to implement ba for people with depression in bipolar disorder and study if it is feasible for this patient group. the second aim is to do a pilot study on the effectiveness of the treatment for this patient group. the research will be implemented with people seeking treatment at the specialized service for bipolar disorder at landspítali university hospital in iceland. the participants will receive treatment as usual and the ba will be adjunctive. at least ten people, that are currently experiencing bipolar depression and are willing to take part, will receive up to 20 individual therapy sessions of ba that have been adapted for bipolar depression (ba-bd), and will complete regular questionnaires and interviews. the study will be a replication study to validate the previous study's findings by kim, w. et al., 2022 in another setting.


Eligibility criteria:
inclusion criteria: * scoring in the clinical range on a self-report measure of depression severity (the phq-9) meeting diagnostic criteria for depression based on a diagnosis on diagnostic interview for anxiety, mood, and ocd and related neuropsychiatric disorders (diamond) meeting diagnostic criteria for bipolar i or ii disorder diamond) participants will require a working knowledge of written and spoken icelandic, sufficient to make use of therapy and complete research assessments without the need for a translator. exclusion criteria: * current/past learning disability, organic brain change, substance dependence (drugs and alcohol) that would compromise the ability to use therapy * current marked risk to self (i.e., self-harm or suicide) that we deem could not be appropriately managed in the bipolar outpatient clinic at landspitali. * currently lacking the capacity to give informed consent * currently receiving other psychosocial therapy for depression or bipolar disorder * presence of another area of difficulty that the therapist and client believe should be the primary focus of intervention (for example, post-traumatic stress disorder, psychosis)

Keywords: bipolar depression bipolar disorder behavioural activation depression
a randomized clinical trial of home-based exercise combined with a slight caloric restriction on obesity prevention among women

Conditions: Obesity Prevention

Summary: the study investigated the effectiveness of home-based exercise combined with a slight caloric restriction on weight change during 12 months in non-obese women. in addition the investigators evaluate the effects of baseline insulin resistance on modulation of weight change. a randomized clinical trial with a factorial design was conducted from 2003 to 2005. two hundred three middle-aged women (rio de janeiro/brazil), 25-45 years, were randomly assigned to one of two groups: control (cg) and home-based exercise (hb). the hb group received a booklet on aerobic exercise that could be practiced at home (3 times/week - 40 min/session), in low-moderate intensity, during 12 months. both groups received dietary counseling aimed at a slight energy restriction of 100-300 calories per day. the hb experienced a greater weight loss in the first 6 months (-1.4 vs. -0.8 kg; p=0.04), but after 12 months there was no differences between groups (-1.1 vs. -1.0; p=0.20). of the serum biochemical markers, hdl-cholesterol showed major change, with an increase at month 12 of 18.3 mg/dl in the hb compared to 9.5 in the cg (p\<0.01). at baseline the non-ir group (n=121) compared to ir (n=64) had similar values of bmi (26.7 vs. 26.3 p=0.21), but statistically significant lower values of waist, glucose, insulin and homa-ir, as expected. when the group non-ir and ir were further stratified by gi diet, there were no differences according to diet in both groups. women classified as ir at baseline had greater weight loss after 12 months of follow-up (-1.62 kg vs. -1.08 kg; p=0.01), and hb exercise helped to reduce weight only among nir women (-1.51 vs. -0.68; p=0.04); no differences were observed between intervention groups for ir women (-1.54 vs. -1.66; p=0.24). there were no differences between ir and nir groups for lipid profile after adjustment for weight changes. during follow-up, changes were more pronounced among those women in the high gi diet. these differences were statistically significant for weight and bmi and were greater among the ir compared to the non-ir. changes in homa-ir after 3 months of follow-up were different comparing non-ir with ir at baseline. the ir had a reduction in the homa-ir, whereas in the non-ir this value increased (-0.73 vs. +0.37; p=\<0.001). also this reduction was greater among high compared to low gi diet (p=0.04).


Eligibility criteria:
inclusion criteria: non-obese women aged 25-45 years exclusion criteria: physician-diagnosed thyroid disease or diabetes or who were menopausal or any other disease that could be influenced by intervention

Keywords: overweight; treatment; women
evaluation of tumor resection guided by intraoperative indocyanine green dye fluorescence angiography in patients with sarcoma

Conditions: Bone Sarcoma; Soft Tissue Sarcoma

Summary: this study evaluates the effectiveness of intraoperative indocyanine green dye and fluoroscopic technology in confirming negative margins after tumor removal.

primary objective: i. to evaluate the use of indocyanine green (icg) as an intraoperative guide during bone and soft tissue sarcoma resection. outline: this is an observational study. patients receive icg infusion prior to undergoing scheduled resection and have medical records reviewed on study.

Eligibility criteria:
inclusion criteria: * patients with biopsy-proven bone or soft tissue sarcoma undergoing resection exclusion criteria: * \* age less than 18 * chronic kidney disease * anaphylaxis to dyes
comparison of desflurane with sevoflurane for school-age children in postoperative cognitive function

Conditions: Postoperative Cognitive Dysfunction

Summary: this study compares desflurane with sevoflurane for school-age children in postoperative cognitive function.

the postoperative cognitive dysfunction (pocd) of school-age children (6-14 age) after operation draw more attention from both society and family. it is well known that, compare with sevoflurane, desflurane could improve cognitive function in elderly patients. but whether desflurane could improve postoperative cognitive function compare with sevoflurane for the school-age children, there is no consistent conclusion.

Eligibility criteria:
inclusion criteria: * 6-14 age, elective no-cardiac and non-neurological surgery , asa physical statusⅰorⅱ, no preoperative cognitive function impairment, cooperate to complete the entire test. exclusion criteria: * allergic to halogens inhaled anesthetics, malignant hyperthermia susceptible patients, intracranial hypertension, emotional disorder, hyperactivity, history of operation, mental retardation, audio-visual obstacles, history of congenital heart disease, important organ dysfunction, history of drug abuse * history of epilepsy * preoperative respiratory infection significantly.

Keywords: desflurane sevoflurane
patupilone (epo 906) in patients with recurrent or progressive glioblastoma

Conditions: Recurrent Glioblastoma Planned for Reoperation

Summary: patupilone trial for patients with recurrent glioblastoma, which are planned for re-operation. objectives: prolongation of pfs compared to patients with re-operation only, patupilone tumor concentrations, pharmacokinetic, perfusion in mri pre - and post patupilone. translational research of tumor tissue exposed to patupilone. * trial with medicinal product

prior to and after re-operation patients with recurrent glioblastoma receive the investigational drug patupilone, a tubulin-inhibitor. the purpose of the trial is to prolong pfs in this patient population. patupilone is already used in clinical trials of other tumor entities such as ovarian cancer, breast and lung cancer. side effects are expected to be manageable.

Eligibility criteria:
inclusion criteria: * recurrent glioblastoma at least 2 cm in diameter after standard treatment (surgery, radiotherapy and chemotherapy), which has to be completed at least three weeks earlier. * \> 18 years of age, kps 70-100% * no liver disease, no malignancies (except curative treated skin tumors, dcis of the breast and curative treated cervix carcinoma) * lc \> 3000 und tc \> 100 000, hb\> 9, bilirubin \</= 1.5mg/dl, ast/alt less than 2.5 x upper limit, creatinine \</= 132umol/l * no pregnancy or breast feeding * written informed consent prior to study entry * no reasons for incompliance * reoperation planned exclusion criteria: * kps \< 70% * radiotherapy- or chemotherapy within 6 weeks * enzyme inducing medication or st john's wort * other study medication within 28 days * other malignancies * intolerance of patupilone * prior patupilone * neuropathy \> grad 1 * other life threatening illnesses * acute or chronic liver diseases * hiv infection * known non-compliance in medication intake,inability to give informed consent * cardiac problems (nyha iii oder iv) with uncontrolled insufficiency or angina pectoris * active or uncontrolled infection * pregnancy or breast feeding * hematologic growth factors (without erythropoetin) colostomy * patients with uncontrolled diarrhea in the last 7 days prior to study entry.

Keywords: recurrent glioblastoma
geolocation positional system (gps) experience

Conditions: Emotions; Anhedonia; Depression

Summary: the purpose of this study is to use smartphone technology to capture individual location emotional and cognitive data, to examine how real-world behaviors thoughts, emotions, and brain activity are related to one another.

the observational portion of this study was initially approved in 2015, this is a subset of the initially approved study and it is a clinical trial of 100 participants.

Eligibility criteria:
inclusion criteria: * must agree to give informed consent * must be willing to have an functional magnetic resonance imaging (fmri) scan * must be able to receive and respond to daily text messages assessing current emotion * must be willing to download and run a gps tracking application (followmee) onto their smartphone for a four-month period exclusion criteria: * history of head trauma, seizures, or neurological disorders * severe/unstable medical conditions * conditions that interfere with mri * pregnancy * lifetime psychotic/bipolar disorder * chronic/severe substance or alcohol abuse/dependence * antipsychotic medication
surgery for masaoka-koga i-ii thymoma

Conditions: Thymoma; Masaoka Stage I; Masaoka Stage II

Summary: the purpose of this study was to evaluate the safety and perioperative outcomes of the subxiphoid approach versus the lateral intercostal approach thoracoscopic thymectomy for masaoka-koga i-ii thymoma.

it is a multi-center, open, prospective randomized phase ii\&iii clinical trial sponsored by shanghai zhongshan hospital with other four hospitals in china participating in. 100 patients with thymoma (masaoka-koga i-ii ) diagnosed by enhanced computed tomography were recruited and randomly assigned into the subxiphoid approach thoracoscopic thymectomy (satt group) and the lateral intercostal approach thoracoscopic thymectomy (latt group) according to the proportion of 1:1. the safety and perioperative outcomes are compared between the two surgical regimens.

Eligibility criteria:
inclusion criteria: 1. thymoma was diagnosed by chest enhanced ct (clinical stage: masaoka koga i-ii); 2. the patients whose tumor diameter was \<6 cm; 3. the patients with age ≥ 18 and ≤ 75 years old, the estimated survival time should be over 12 months; 4. asa grade：1-2; 5. the patients should have no functional disorders in main organs.; 6. the patients should be able to understand our research and sign the informed consent. exclusion criteria: 1. imaging examination showed that the tumor had invasion of surrounding organs, pleural or pericardial dissemination, lymphatic or hematogenous metastasis; 2. patients with myasthenia gravis; 3. patients had undergone a sternotomy; 4. the patients have proved history of congestive heart failure, angina without good control with medicine; ecg-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control; 5. the patients have severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy; 6. female who is positive for serum pregnancy test or during lactation period; 7. the patients have history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation; 8. the patients have history of peripheral nerve system disorders, obvious mental disorders or central nerve system disorders; 9. the patients attend other clinical trials.

Keywords: thymoma (masaoka stage i-ii) the subxiphoid approach the lateral intercostal approach
risk of major adverse cardiovascular events for naldemedine & other medications for opioid induced constipation

Conditions: Opioid-induced Constipation

Summary: the research objective is to characterize the risk of a major adverse cardiovascular event (mace) among new users of naldemedine versus new users of lubiprostone and new users of naloxegol as comparator opioid induced constipation (oic) medications.

this is a prevalent new user cohort study conducted using multiple databases linkable to medical records and the national death index (ndi) to assess mace risk among adult patients with chronic non-cancer pain receiving naldemedine or a comparator oic medication. the uptake of naldemedine and comparator oic medications will be monitored for each database annually until a sufficient number of patients to support the comparative analyses in the safety assessment phase is accrued. the safety assessment phase will commence at the conclusion of the monitoring phase.

Eligibility criteria:
inclusion criteria: * at least one dispensing of naldemedine or lubiprostone or naloxegol without prior use in the database of either medication (index date) * at least two dispensings of opioids within six months prior to and including the index date, with at least a combined 31 cumulative days supply * at least 18 years of age or older on the index date * at least six months of continuous health plan coverage that includes medical and pharmacy benefits prior to and including the index date exclusion criteria: * any acute mace (non-fatal mi or non-fatal stroke) within six months before or on the index date * any cancer treatment or cancer pain diagnosis within six months before or on the index date * prior use of methylnaltrexone, alvimopan or naloxegol within six months before or on the index date

Keywords: naloxegol major adverse cardiovascular event (mace) opioid induced constipation (oic) lubiprostone naldemedine
nicotine patch for nicotine dependence in individuals with schizophrenia or schizoaffective disorder - 1

Conditions: Tobacco Use Disorder

Summary: the purpose of this study is to test the use of high-dose versus regular-dose nicotine patch for nicotine dependence in individuals with schizophrenia or schizoaffective disorder

this is a randomized double-blind placebo controlled 8 week outpatient medication clinical trial to evaluate the relative efficacy of high-dose (42mg) versus regular dose (21mg) nicotine patch treatment for individuals with schizophrenia or schizoaffective disorder and nicotine dependence. it also has a placebo controlled continuation phase to examine if longer duration of treatment is more effective than a standard eight week dosing schedule. the literature supports that schizophrenics have an increased rates of smoking and are more likely to be dependent on nicotine. nicotine gum and patches are safe and now approved for over the counter sale in the united states. high dose patch therapy is well tolerated and provides more complete nicotine replacement. this improves withdrawal symptom relief and it is hypothesized that abstinence rates from smoking will be greater in the high dose patch group. few trials have examined the usefulness of nicotine replacement therapy in this population and preliminary evidence shows lower than expected success rates of smoking cessation with conventional treatments

Eligibility criteria:
inclusion criteria: subjects: 100 stable outpatients with schizophrenia and schizoaffective disorder and nicotine dependence. all subjects will meet the following inclusion criteria: * patients who are able to provide informed consent * patients will meet dsm-iv diagnostic criteria for nicotine dependence and schizophrenia or schizoaffective disorder * patients will be stable on their current antipsychotic regimen and will be interested in treatment for both their psychiatric and nicotine dependence exclusion criteria: * potential subjects meeting the following criteria will be excluded: * patients with history of clinically significant angina or unstable angina pectoris * patients with severe cad or recent myocardial infarction (within last 6 months) * patients with evidence or history of other severe medical illness (hematologic, renal or neoplastic) * patients who represent a serious suicide risk, including recent suicidal behavior or attempt within the last thirty days * patients with history of severe skin allergies or chronic dermatoses * concomitant use of clonidine or bupropion * pregnant females
dexamethasone vs methylprednisolone for the treatment of patients with ards caused by covid-19

Conditions: Covid19; ARDS

Summary: a randomized clinical trial designed and intended to evaluate the efficacy of dexamethasone and methylprednisolone as a treatment for severe acute respiratory distress syndrome (ards) caused by coronavirus disease 19 (covid-19). our aim is to find the best option for the treatment and management of ards in covid-19 patients.


Eligibility criteria:
inclusion criteria: • moderate to severe covid-19 requires hospitalization. sars-cov-2 infection will be confirmed by rt pcr / ct chest in every case. exclusion criteria: * participants with uncontrolled clinical status who were hospitalized from the before. * contraindication / possible drug interaction. * participants who have any severe and/or uncontrolled medical conditions like, severe ischemic heart disease, epilepsy, malignancy, pulmonary/renal/hepatic disease, pregnancy, corpulmonale, etc.

Keywords: covid 19 dexamethasone methylprednisolone ards
personalized second chance breast conservation (pscbc): a prospective phase ii clinical study

Conditions: Breast Cancer

Summary: the goal of the study is to investigate the feasibility of enabling a second chance for breast conservation in patients with in-breast recurrences after a previous lumpectomy and rt, investigators propose to test partial breast irradiation with the target volume encompassing the entire surgical bed with 1.0-1.5 cm margins.

patients will be treated with the fractionation of 30 gy in 5 fractions over 1-2 weeks, which is the accelerated fractionation scheme of choice for radiation therapy (rt) naïve patients at new york presbyterian using ebrt. the main aim of the study is to evaluate the rate of early grade 3 toxicities with this approach.

Eligibility criteria:
inclusion criteria: * isolated ipsilateral unifocal breast lesions * limited size (\< 2-3 cm) without evidence of skin involvement * histologically proven invasive breast carcinoma or carcinoma in situ * negative histologic margins of resection * patients with 0 to 3 positive axillary lymph nodes without extracapsular extension * no synchronous distant metastases * age ≥ 18 years * ≥ 12 months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence * technical feasibility * every kind of systemic therapy is allowed * informed consent for clinical and research purposes signed exclusion criteria: * regional recurrences (axillary, supraclavicular) * positive histologic margins at resection * metastatic disease * poor cosmesis from previous surgery and rt * previous breast rt performed with iort, brachytherapy or previous partial breast treatment * extensive intraductal component